Monolithic medical devices, methods of making and using the same

ABSTRACT

The monolithic device comprises a plurality of scaffolding members and a mesh patterned members webbed between the scaffolding members; the mesh patterned member webbed between the scaffolding members surround a lumen and generally expands from a contracted state to an expanded state; and mesh patterned members including a plurality of openings traversing the thickness of the mesh patterned member, and the mesh patterned members including a surface on which a pattern of openings is formed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of co-pending U.S. patent applicationSer. No. 14/213,974 filed Mar. 14, 2014; which claims priority to U.S.Provisional Patent Application Ser. No. 61/788,767, filed on Mar. 15,2013 and U.S. Provisional Patent Application Ser. No. 61/783,330, filedon Mar. 14, 2013 the disclosures of which are hereby incorporated byreference.

BACKGROUND

The invention generally relates to medical devices.

Various types of intravascular stents have been used in recent years. Anintravascular stent generally refers to a device used for the support ofliving tissue during the healing phase, including the support ofinternal structures. Intravascular stents, or stents, placedintraluminally, as by use of a catheter device, have been demonstratedto be highly efficacious in initially restoring patency to sites ofvascular occlusion. Intravascular stents, or stents, may be of theballoon-expandable type, such as those of U.S. Pat. Nos. 4,733,665;5,102,417; or 5,195,984, which are distributed by Johnson & JohnsonInterventional Systems, of Warren, N.J., as the Palmaz™ and thePalmaz-Schatz™ balloon-expandable stents or balloon expandable stents ofother manufacturers, as are known in the art. Other types ofintravascular stents are known as self-expanding stents, such as Nitinolcoil stents or self-expanding stents made of stainless steel wire formedinto a zigzag tubular configuration.

Prior art stents have some functional limitations due to their currentdesign. For example, the prior art stent can collapse when it is bentaround a sharp angle. What is needed is an improved stent that is moreflexible and can be implanted in tightly bent vessels.

SUMMARY OF THE INVENTION

Provided herein are systems, methods and compositions for monolithicmedical devices and methods making and using the same.

The methods, systems, and apparatuses are set forth in part in thedescription which follows, and in part will be obvious from thedescription, or can be learned by practice of the methods, apparatuses,and systems. The advantages of the methods, apparatuses, and systemswill be realized and attained by means of the elements and combinationsparticularly pointed out in the appended claims. It is to be understoodthat both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the methods, apparatuses, and systems, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying figures, like elements are identified by likereference numerals among the several preferred embodiments of thepresent invention.

FIG. 1 is a diagram of one embodiment of a method to make a monolithicmedical device.

FIG. 2 is a diagram of one embodiment of a method to make a monolithicmedical device.

FIG. 3A is a perspective view of one embodiment of a monolithic medicaldevice.

FIG. 3B is an enlarged view of a section of the device of FIG. 3A,showing the scaffolding members and the mesh patterned members.

FIG. 4A is a perspective view of one embodiment of a monolithic medicaldevice.

FIG. 4B is an enlarged view of a section of FIG. 4A showing the scaffoldmembers and the mesh patterned members.

FIG. 5A is a perspective view of one embodiment of the monolithicmedical device.

FIG. 5B is an enlarged view of a section of FIG. 5A showing the scaffoldmembers and the mesh patterned members.

FIGS. 6A-6B, are enlarged photographs of the photoresist and the exposedmetal from the metal tube 600 is shown after steps 105 through 120 andsteps 205 through 220 from FIGS. 1-2, at 100× magnification.

FIG. 6C shows an embodiment of the device after steps 125 through 130and steps 225 through 230 from FIGS. 1-2, displaying the scaffoldingmembers and mesh surface that can be later patterned by laser machiningor chemically machining.

FIG. 7 is a perspective view of one embodiment of a monolithic devicepreserving flow in a blood vessel while diverting flow from an aneurysm.

FIG. 8A is a perspective view of one embodiment the monolithic device.

FIG. 8B is an enlarged view of a photograph of the distal end of oneembodiment of the monolithic device, in the expanded configuration at50× magnification.

FIG. 8C is an enlarged view of a photograph of the embodiment of themonolithic device of FIG. 8B, in the unexpanded configuration at 100×magnification.

FIG. 8D is an enlarged view of a photograph of the distal end of theembodiment of the monolithic device of FIG. 8B, in the unexpandedconfiguration at 100× magnification.

FIG. 9 is an enlarged view of a photograph of one embodiment of themonolithic device in a bent configuration.

FIG. 10 is an enlarged side view of a photograph of one embodiment ofthe monolithic device crimped around a guidewire.

FIG. 11A is a side view of an enlarged photograph of the distal end ofan alternative embodiment of the monolithic device.

FIG. 11B is an exploded version of portion 11B from FIG. 11A of the sideview of the distal end of an alternative embodiment of the monolithicdevice.

FIG. 11C is a side view of an enlarged photograph of the distal end ofthe alternative embodiment of the monolithic device of FIG. 11A.

DETAILED DESCRIPTION OF THE INVENTION

The foregoing and other features and advantages of the invention areapparent from the following detailed description of exemplaryembodiments, read in conjunction with the accompanying drawings. Thedetailed description and drawings are merely illustrative of theinvention rather than limiting, the scope of the invention being definedby the appended claims and equivalents thereof.

In one aspect, the present invention comprises a monolithic medicaldevice and a method of making monolithic medical devices.

Generally speaking, the monolithic device may comprise a covered stent300, as shown in FIG. 3A. In one embodiment, the monolithic device canbe used to prevent plaque from embolizing downstream during a stentplacement. The covered (or webbed) stent 300 comprises of a plurality ofscaffolding members 310 and a mesh patterned members 320 webbed betweenthe scaffolding members 310. The mesh patterned member 320 webbedbetween the scaffolding members 310 surround a lumen 302 and maygenerally expand from a contracted state to an expanded state. Thescaffold members 310 may generally for polygonal shapes, including, butnot limited to, squares, rectangles, trapezoids, pentagons,diamond-shapes, hexagons, octagons, circles, ellipses, and the like. Themesh patterned member 320 may general includes a plurality of openings330 traversing the thickness of the mesh patterned member 320. The meshpatterned members 320 includes a surface on which a pattern of openings330 is formed. The covered stent 300 can be monolithically constructedout of one starting work-piece tube using subtractive processing. Thecovered stent made monolithically is favored due the fact that thetedious and often questionable joining/assembly of the two components ashistorically achieved could possibly be circumvented, in-turnpotentially improving quality and performance while reducing overallcosts. The monolithically constructed covered stent ensures a securebond between the scaffolding members 310 and the mesh patterned member320 webbed between the scaffolding members 310 about the entire lengthand circumference of the device.

FIG. 1 highlights the process flow steps 100 of how the monolithiccovered stent may be made according to one embodiment. A start tube isprepared 105, and then photoresist is applied to the start tube 110. Thestart tube may be a wrought metal, polymer, composite, or ceramic tube,or may be vacuum deposited metal or polymer tube. The start tube may befabricated by a deposition procedure as disclosed in commonly assignedU.S. patent application Ser. No. 13/788,081, filed Mar. 7, 2013 or inU.S. patent application Ser. No. 13/099,980, filed May 3, 2011, hereinincorporated by reference in their entireties. Alternatively, themonolithic device may be produced from drawn metal or polymer tubing, orwrought tubing, provided that fatigue life is adequate. Radiopaquemarkers could be added as an interdispersed deposited layer or a ternaryalloy deposition (e.g., NiTiTa or NiTiNb) if vacuum deposition is used.Different metal layers may be used to form the monolithic device. Thepositioning of the layers can be optimized for mechanical, or otherreasons. Furthermore, ternary additions to binary Nitinol can be used tostrengthen or otherwise alter the material properties, allowing forlower profile devices, enhanced fatigue resistance, etc. These ternaryadditions can also double as radiopacity enhancers. The stent pattern isthen exposed 115 and the stent pattern's exposed photoresist isdeveloped 120. Methods for UV exposure of the pattern (stent or mesh)can include using contact mask methods, non-contact methods (e.g., DLPpattern projection), or UV laser writing. Then the stent pattern ischemically machined 125, and the photoresist is removed 130. Photoresistis then reapplied 135, and the mesh pattern is exposed 140. The exposedphotoresist for the mesh pattern members is developed 142, and the meshpattern members are chemically machined 144. The final step is to removethe photoresist 146. Photo-chemical machining enables the tiered levelsof tube wall material from which the stent scaffold and fine meshpatterned members can be made. Steps 105 through 130 shown in FIG. 1detail how the larger scaffolding patterns of a stent may be chemicallymachined to achieve a partial through-wall pattern. It is preferred thatthe photoresist be coated electro-phoretically due to the nature of thecoating process that results in uniform and even conformal coatings overcomplex 3D work-piece geometries. Steps 135 through 146 highlightmethods for machining the fine mesh pattern(s) within the cells of thelarger stent struts either by using photo-chemical or laser machining.The machining and patterning herewith may use the methods of commonlyassigned U.S. patent application Ser. No. 13/801,173, filed Mar. 13,2013, and incorporated by reference herein in its entirety.Alternatively, the mesh pattern members may include grooved featuresalong with the openings on at least one surface of the monolithicdevice. In other embodiments, the pattern may be a plurality ofmicrogrooves imparted onto the luminal and/or abluminal surface of themonolithic device, as is more fully described in U.S. patent applicationSer. No. 13/654,923, filed Oct. 18, 2012, which is commonly assignedwith the present application and is hereby incorporated by reference inits entirety. The plurality of microgrooves may be formed either as apost-deposition process step, such as by etching, or during deposition,such as by depositing the stent-forming material onto a mandrel whichhas a microtopography on the surface thereof which causes the metal todeposit with the microgroove pattern as part of the deposited material.

An alternative process 200 is shown in FIG. 2, which comprises thepreparation of the start tube 205, and applying a photoresist to thestart tube 210. Then, the stent pattern is exposed 215 and thephotoresist is developed for the stent pattern 220. The stent pattern isthen chemically machined 225, and the photoresist is removed 230. Thelast step is to laser machine the mesh pattern 240.

The processes 100 and 200 previously mentioned include the use ofelectrophoretically depositable (ED) photoresist, and photochemicalmachining of a 3D work-piece geometry to make the monolithic medicaldevice. The use of ED photoresist allows for pattern designs thatencompass different circumferential planes, which is necessary for themonolithic covered stent to resolve the stent and mesh patterns. Throughthe methods 100 and 200 disclosed above, a vast assortment of stent andmesh patterns may be formed which enable optimal designs.

Although it is preferable that the photoresist be applied to thework-piece tube (or other geometry) electrophoretically using either ananionic or cationic electrophoretic depositable photoresist, thephotoresist may be applied using other techniques including but notlimited to lamination, spraying, dipping, or Chemical Vapor Deposition(CVD). Although chemical machining has been initially disclosed as themethod for through-resist machining, other selective methods includingbut not limited to reactive ion etching (RIE), dry etching,electrochemical machining, or photo-activated chemical machining may beused. RIE may utilize Cl or F (or mixtures thereof) based chemistries orothers compatible with etching SS, PtCr, Nitinol, SS, CoCr alloys (toinclude MP35N and L-605). Dry etching may use inert gases such as Ar,Kr, Xe, and the like.

As shown in FIG. 3B, the device 300 includes a plurality of scaffoldmembers 310 and mesh patterned members 320 webbed between thescaffolding members 310. The scaffolding members 310 may include araised surface feature that includes a thickness T above the surface ofthe mesh patterned members 320. The mesh patterned members 320 may formgenerally polygonal shapes with the scaffolding members 310 forming theborders thereabout. A plurality of openings 330 may be patterned in afirst row 332, a second row 334, and/or a third row 336 in the meshpatterned members 320. The scaffolding members 310 may intersect atpoints 312 to form larger hinge regions 312 to allow for the expansionof the scaffolding members 310. In one embodiment, the mesh patternedmembers 320 have a length or a width between at least 0.1 to 50.0microns in length or width, alternatively between at least 10.0 to 100.0microns in length or width, or alternatively between at least 1.0 to1000.0 microns in length or width. The length and/or width of the meshpatterned members 320 may be selected according to the type of patternand openings employed with the mesh patterned members.

An alternative embodiment of the monolithic medical device 400 is shownin FIGS. 4A-4B. The monolithic medical device 400 comprises a pluralityof scaffold members 410 interconnected by a plurality of mesh patternedmembers 420. The mesh patterned members 420 may include a plurality ofopenings 430 throughout the surface of the mesh patterned members 420,and exterior borders 422 around the perimeters of the mesh patternedmembers 420, as shown in FIG. 4B. The plurality of openings 430 maygenerally form a diamond shaped pattern 432. The generally diamondshaped pattern 432 may generally include between at least 4 to 16openings 430 in a mesh patterned member 420. Generally, the scaffoldmembers 410 include a thickness T that is raised from the surface of themesh patterned members 420, and the scaffold members 410 intersect athinge regions 412.

An alternative embodiment of the monolithic medical device 500 is shownin FIGS. 5A-5B. The monolithic medical device 500 may comprise aplurality of scaffold members 510 interconnected by a plurality of meshpatterned members 520. The mesh patterned members 520 may include aplurality of openings 530 in the corner features of the mesh patternedmembers 520, and a plurality of L-shaped openings 532 traversing thewidth and length of the mesh patterned members 520. In one embodiment,each corner opening 530 includes at least 2 to 5 L-shaped openings 532of progressively larger L-shapes. As shown in FIG. 5B, corner openings530 adjacent to scaffold members 510 may be a different size. Generally,the scaffold members 510 include a thickness T that is raised from thesurface of the mesh patterned members 520, and the scaffold members 510intersect at hinge regions 512.

As shown in FIGS. 6A-6B, the photoresist and the exposed metal from themetal tube 600 are shown after steps 105 through 120 and steps 205through 220. The exposed photoresist 610 defines the location of thescaffold members and the exposed metal 620 is shown for locations of themesh pattern members. FIG. 6C shows the result of steps 125 through 130and steps 225 through 230, displaying the scaffold members 630 and meshpattern surface 640 that can be later patterned by laser machining orchemical machining.

The monolithic device may be used with any type of cell, which cell hasa cellular membrane. Most distinct cell types arise from a singletotipotent cell that differentiates into hundreds of different celltypes during the course of development. Multicellular organisms arecomposed of cells that fall into two fundamental types: germ cells andsomatic cells. During development, somatic cells will become morespecialized and form the three primary germ layers: ectoderm, mesoderm,and endoderm. After formation of the three germ layers, cells willcontinue to specialize until they reach a terminally differentiatedstate that is much more resistant to changes in cell type than itsprogenitors. The ectoderm differentiates to form the nervous system(spine, peripheral nerves and brain), tooth enamel and the epidermis(the outer part of integument). It also forms the lining of mouth, anus,nostrils, sweat glands, hair and nails. The endoderm forms thegastrointestinal tract cells, the respiratory tract cells, the endocrineglands and organ cells, the auditory system cells, and the urinarysystem cells. The mesoderm forms mesenchyme (connective tissue),mesothelium, non-epithelial blood cells and coelomocytes. Mesotheliumlines coeloms; forms the muscles, septa (cross-wise partitions) andmesenteries (length-wise partitions); and forms part of the gonads (therest being the gametes).

The inventive monolithic devices may be intravascular stents,stent-grafts, grafts, heart valves, venous valves, filters, occlusiondevices, catheters, sheaths, osteal implants, implantablecontraceptives, implantable antitumor pellets or rods, shunts andpatches, pacemakers, needles, temporary fixation rods, medical wires ormedical tubes for any type of medical device, or other implantablemedical devices, as will also be hereinafter described. A pacemaker (orartificial pacemaker, so as not to be confused with the heart's naturalpacemaker) is a medical device that uses electrical impulses, deliveredby electrodes contacting the heart muscles, to regulate the beating ofthe heart. The electrodes may be covered by tubing or other materialthat includes a surface that may require endothelialization and groovesthereon. Earrings and other piercings may benefit from the topographicalfeatures, as well as any other implant, whether the implant is anorganic, inorganic, mechanical, electrical, or biological device.

In some embodiments, the monolithic device is formed from a metal, apolymer, a composite, or a ceramic material. In some embodiments,materials to make the inventive stents are chosen for theirbiocompatibility, mechanical properties, i.e., tensile strength, yieldstrength, and their ease of deposition include the following: elementaltitanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium,silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt,palladium, manganese, molybdenum and alloys thereof, such aszirconium-titanium-tantalum alloys, nitinol, and stainless steel.

In another aspect, the present invention may comprise a monolithicmedical device and a method of using the monolithic medical device.

Generally speaking, the monolithic device 700 may comprise a low profilestent that promotes thrombosis of an aneurysm 12 by diverting blood flowthrough the parent vessel 10, as shown in FIG. 7. As shown in FIG. 8A,the monolithic device 700 comprises an ultra-dense stent cell pattern710 including a plurality of structural members 720 that diverts themajority of blood flow without restricting blood flow completely, thusproviding the opportunity for the aneurysm to shrink over time. Themonolithic device includes an expanded state and a contracted state fordelivery. The monolithic device may include an end ring 730 on theproximal and/or distal ends. This monolithic device may alternatively beused as an embolic protection stent cover or in any other applicationwhere a low profile, high density pattern is desirable. Alternatively,the monolithic device may be used a liner for a catheter tip,scaffold/indenter for drug-eluting balloons, and vascular stenting,including; vulnerable plaque containment (carotid, coronary), flowdiversion, adjunct to coiling (neurological), and vascular perforation.

As shown in FIG. 8B, the expanded monolithic device 700 includes the endring 730 on either the proximal or distal end or both ends of the device700. The ultra-dense cell pattern 710 includes a first Z-pattern 740 ofthe structural members 720 and a second Z-pattern 742 of the structuralmembers 720. The first and second Z patterns 740, 742 form a pluralityof peaks 744 and a plurality of troughs 746 along the longitudinal axis702. The first and second Z patterns 740, 742 are interconnected by aplurality of curved interconnecting members 750 that connect a peak 744of the first Z pattern 740 with a trough 746 of the second Z pattern742. Preferably, the curved interconnecting members 750 do not connectadjacent peaks 744 of the first Z pattern to adjacent troughs 746 of thesecond Z pattern. In one embodiment, the curved interconnecting members750 connect a peak 744 of the first Z pattern with a trough 746 of thesecond Z pattern that is displaced along the longitudinal axis and atleast one trough below the peak 744 along the vertical axis 704 of themonolithic device 700. In other embodiments, the curved interconnectingmembers 750 may connect a peak 744 of the first Z pattern 740 with atrough 746 of the second Z pattern 742 that is at least two troughsbelow the peak 744 along the vertical axis 704 of the monolithic device.This connection of the peak 744 of the first Z pattern 740 with anonadjacent trough 746 of the second Z pattern 742 by the curvedinterconnecting member 750 forms the curved portion of the curvedinterconnecting member 750. As shown in FIGS. 8B-8C, the second Zpattern 742 is connected with a second set of curved interconnectingmembers 752 at the peak 744 that is angled at an opposite angle ornon-parallel angle from the first set of the curved interconnectingmembers 750. The opposite or non-parallel angle may be between about10-100 degrees, alternatively, between about 20-90 degrees,alternatively, between about 30-80 degrees. The tight first and second Zpatterns 740, 742 allow the monolithic device to maintain adequateradial force despite its small size. The interior cell structure 710could be modified to optimize performance.

As shown in FIGS. 8B-8D, the end ring 730 includes an end Z pattern 732comprising a plurality of peaks 734 and a plurality of troughs 736. Inone embodiment, a peak 734 of the end ring 730 connects to every othertrough 746 of the first Z pattern 740, such that the peak 734 of eachend Z pattern 730 does not connect to adjacent troughs 746 of the firstZ pattern 740. This connection forms a larger end Z pattern 732. In oneembodiment, the peak 734 of the end Z pattern 732 connects to everythird trough 746 of the first Z pattern 740, while in other embodimentsthe peak 734 may connect to every fourth trough 746 of the first Zpattern 740. The modified end rings of the stent geometry can preventcell migration as well as be used for marker placement. Alternatively,the end rings could be modified or eliminated completely from themonolithic device.

As shown in FIG. 9, the monolithic device 700 may be bent along itslongitudinal axis to conform to the shape or curvature of a bloodvessel. After being deployment and bending along its longitudinal axis,the monolithic device 700 is retrievable. The spacing between the curvedinterconnecting members 750 and 752 is maintained between about least0.1 and 20 microns, and the spacing between the peaks 744 and thetroughs 746 of the first and second Z patterns 740, 742 is maintainedbetween about at least 0.1 and 20 microns to permit blood flowtherebetween. The monolithic device 700 is able to bend, while the wallthickness of the monolithic device 700 is between about 0.1-100.0microns.

As shown in FIG. 10, the monolithic device 700 may be crimped around aguide wire 790. The crimping may collapse the first Z pattern 740, theend ring 730, and the curved interconnecting members 750 to a diameterbetween about 0.2 and 2.0 mm. After the monolithic device 700 isuncrimped, the monolithic device 700 may expand to a diameter betweenabout 2.0 and 7.0 mm while maintaining adequate radial force and wallapposition. In one embodiment, the wall thickness of the monolithicdevice 700 is less than about 75 microns.

An alternative embodiment of the monolithic device is shown in FIGS.11A-11C. The monolithic device 800 comprises a dense cell pattern 810and may include circumferential ring members comprising a first Zpattern 840, a second Z pattern 842, and a plurality of looped orgenerally S-shaped interconnecting members 850 connecting the first Zpattern 840 and the second Z pattern 842. The proximal and/or distal endof the monolithic device 800 may include an end ring 830 in an end Zpattern 832 that is connected to the first Z pattern 840. The first andsecond Z patterns 840, 842 include a plurality of interconnected peaks844 and troughs 846. As shown in FIG. 11B, the peak 844 of the first Zpattern 840 is connected to the first end 852 of the looped or S-shapedinterconnecting member 850, whereby the first end 852 of the looped orS-shaped interconnected member 850 forms a generally first loop or firstgenerally elliptical section 854 facing the proximal end of themonolithic device 800, while the first loop or first generallyelliptical section 854 connects to a second loop or second generallyelliptical section 856 that faces in the opposite direction of the firstloop or first generally elliptical section 854 and towards the distalend of the monolithic device. The second loop or second generallyelliptical section 856 ends at the second end 858 that is connected tothe trough 846 of the second Z pattern 842. In one embodiment, the firstloop or first generally elliptical section 854 fits within the peak 844of the second Z pattern 844, and the second loop or second generallyelliptical section 856 fits within the trough 846 of the first Z pattern840. As shown in FIG. 11C, the end ring 830 includes an end Z pattern832, which includes a plurality of interconnected peaks 834 and troughs836. The peak 834 of the end Z pattern 832 connects with the trough 846of the first Z pattern 840, and in one embodiment, the peak 834 of theend Z pattern 832 connects with every other trough 846 of the first Zpattern 840, or every third trough 846 of the first Z pattern 840.Optionally, the end Z pattern 832 may include additional peaks 834 b andtroughs 836 b, whereby the peaks 834 b are to the troughs 836, as tofurther extend the distal end. A radiopaque layer 860 of Tantalum may bebetween two layers of metal for the monolithic device 800. The Tantalumradiopaque layer is the white layer 860 that appears as a stripe alongthe side walls of the stent, as shown in FIG. 11B. Alternatively,radiopaque layer 860 may comprise another biocompatible radiopaquematerial.

In some embodiments as described above and shown in further detail inFIGS. 11A-11C, the first generally elliptical section 854 has a majoraxis generally parallel to a longitudinal axis of the intravascularstent device. The first generally elliptical section further comprises afirst portion 855 connected to a peak of a first circumferential ringmember at a first end of the major axis and to a second portion 857 at asecond end of the major axis. The second portion 857 is further coupledto the second generally elliptical section 856 proximate to the firstend of the major axis. Additionally, the second generally ellipticalsection 856 has a second major axis generally parallel to a longitudinalaxis of the intravascular stent device and circumferentially off-setfrom the major axis. The second generally elliptical section 856 furthercomprises a third portion 859 coupled to the first generally ellipticalsection 854 proximate a second end of the second major axis and furthercoupled to a fourth portion 861 at a first end of the second major axis.The fourth portion 861 is further connected to a peak of the secondcircumferential ring member at the second end of the second major axis.

In additional embodiments as described above and shown in further detailin FIGS. 11A-11C, the intravascular stent device further comprises acurvilinear member 863 connecting the second portion 857 of the firstgenerally elliptical section 854 to the third portion 859 of the secondgenerally elliptical section 856. The curvilinear member 863 is orientedgenerally along a longitudinal axis of the intravascular stent device.

In yet additional embodiments as described above and shown in furtherdetail in FIGS. 11A-11C, the intravascular stent device furthercomprises hinge regions 865 at the junctions of the portions of thegenerally elliptical sections. For example, a hinge region 865interconnects the first portion 855 and the second portion 857 of thefirst generally elliptical section 854 at the second end of the majoraxis of the first generally elliptical section 854 and a second hingeregion 865 interconnects the third portion 859 and the fourth portion861 of the second generally elliptical section 856 at the first end ofthe major axis connect of the second generally elliptical section 856.

In some embodiments, the monolithic device is formed from a materialthat is a metal, a polymer, a composite, or a ceramic material. In someembodiments, materials to make the inventive stents are chosen for theirbiocompatibility, mechanical properties, i.e., tensile strength, yieldstrength, and their ease of deposition include the following: elementaltitanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium,silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt,palladium, manganese, molybdenum and alloys thereof, such aszirconium-titanium-tantalum alloys, nitinol, and stainless steel.

In some embodiments, the monolithic device 700 may be fabricated by aprocedure, as described in U.S. application Ser. No. 13/788,081, filedMar. 7, 2013 or in U.S. patent application Ser. No. 13/099,980, filedMay 3, 2011, herein incorporated by reference in their entireties. Inone embodiment, a coating of deposited metal film or polymer is about0.1-100.0 microns in a tube form, which is laser cut using ultra shortpulsed femtosecond laser to minimize heat affected zones and recast. Thefinal monolithic device may be heat treated to optimize spring backeffects. The stent's one piece construction allows many advantages overmany currently available braided stent designs, such as a lower profile,self-expanding, and ease of manufacturing. Alternatively, the monolithicdevice may be produced from drawn metal or polymer tubing, wroughttubing, provided that fatigue life is adequate. Radiopaque markers couldbe added as an interdispersed deposited layer if vacuum deposition isused. Different metal layers may be used to form the monolithic device.

In some embodiments, the method further comprises the step of patterningat least one surface of the monolithic device. In some embodiments, thepatterning comprises laser patterning to impart at least one feature onthe at least one surface of the monolithic device. In some embodiments,the pattern is a series of grooves on at least one surface of themonolithic device, preferably the surface that will comprise the innerdiameter of the finished stent. In other embodiments, the pattern may bea plurality of microgrooves imparted onto the luminal and/or abluminalsurface of the monolithic device, as is more fully described in U.S.patent application Ser. No. 13/654,923, filed Oct. 18, 2012, which iscommonly assigned with the present application and is herebyincorporated by reference in its entirety. The plurality of microgroovesmay be formed either as a post-deposition process step, such as byetching, or during deposition, such as by depositing the stent-formingmaterial onto a mandrel which has a microtopography on the surfacethereof which causes the metal to deposit with the microgroove patternas part of the deposited material.

The inventive monolithic devices may be intravascular stents,stent-grafts, grafts, heart valves, venous valves, filters, occlusiondevices, catheters, sheaths, osteal implants, implantablecontraceptives, implantable antitumor pellets or rods, shunts andpatches, pacemakers, needles, temporary fixation rods, medical wires ormedical tubes for any type of medical device, or other implantablemedical devices, as will also be hereinafter described. A pacemaker (orartificial pacemaker, so as not to be confused with the heart's naturalpacemaker) is a medical device that uses electrical impulses, deliveredby electrodes contacting the heart muscles, to regulate the beating ofthe heart. The electrodes may be covered by tubing or other materialthat includes a surface that may require endothelialization and groovesthereon. Earrings and other piercings may benefit from the topographicalfeatures, as well as any other implant, whether the implant is anorganic, inorganic, mechanical, electrical, or biological device.

The monolithic device may be used with any type of cell, which cell hasa cellular membrane. Most distinct cell types arise from a singletotipotent cell that differentiates into hundreds of different celltypes during the course of development. Multicellular organisms arecomposed of cells that fall into two fundamental types: germ cells andsomatic cells. During development, somatic cells will become morespecialized and form the three primary germ layers: ectoderm, mesoderm,and endoderm. After formation of the three germ layers, cells willcontinue to specialize until they reach a terminally differentiatedstate that is much more resistant to changes in cell type than itsprogenitors. The ectoderm differentiates to form the nervous system(spine, peripheral nerves and brain), tooth enamel and the epidermis(the outer part of integument). It also forms the lining of mouth, anus,nostrils, sweat glands, hair and nails. The endoderm forms thegastrointestinal tract cells, the respiratory tract cells, the endocrineglands and organ cells, the auditory system cells, and the urinarysystem cells. The mesoderm forms mesenchyme (connective tissue),mesothelium, non-epithelial blood cells and coelomocytes. Mesotheliumlines coeloms; forms the muscles, septa (cross-wise partitions) andmesenteries (length-wise partitions); and forms part of the gonads (therest being the gametes).

In one embodiment, the apparatus comprises: an ultra-dense stent cellpattern including a plurality of structural members that diverts themajority of blood flow without restricting blood flow completely.

While the invention has been described in connection with variousembodiments, it will be understood that the invention is capable offurther modifications. This application is intended to cover anyvariations, uses or adaptations of the invention following, in general,the principles of the invention, and including such departures from thepresent disclosure as, within the known and customary practice withinthe art to which the invention pertains.

What is claimed is:
 1. A monolithic device comprising: a stent cellpattern with a plurality of structural members configured to divert amajority of a fluid flow through the monolithic device without fullyrestricting the fluid flow wherein the stent cell pattern furthercomprises: a plurality of Z-pattern members, wherein the Z-patternmembers include a plurality of peaks and a plurality of troughs along alongitudinal axis of the device, and wherein a first Z-pattern memberand a second Z-pattern member positioned adjacent to the first Z-patternmember are interconnected by a plurality of interconnecting members. 2.The monolithic device of claim 1, further comprising: an end ring memberincluding an end Z-pattern having a plurality of peaks and a pluralityof troughs.
 3. The monolithic device of claim 1, wherein the peaks ofthe end Z-pattern connect to every third trough of a Z-pattern memberpositioned adjacent to the end Z-pattern.
 4. The monolithic device ofclaim 1, wherein spacing between adjacent interconnecting members isbetween about 0.1 and 20 microns when the monolithic device is in adeployed state.
 5. The device of claim 1, wherein the monolithic devicehas a wall thickness between about 0.1 and about 100 microns, andwherein the monolithic device is configured to have: a crimped statewherein the monolithic device has a diameter between about 0.2 and about2.0 mm, and an expanded state wherein the monolithic device has adiameter between about 2.0 and about 7.0 mm.
 6. The monolithic device ofclaim 1, wherein each of the plurality of interconnecting memberscomprises an S-shaped member coupling a first Z-pattern member and asecond Z-pattern member positioned adjacent to the first Z-patternmember, and the S-shaped member further comprises: a first end connectedto a peak of the first Z-pattern member, a first loop facing a first endof the monolithic device, a second loop facing a second end of themonolithic device positioned opposite to the first end of the monolithicdevice, and a second end connected to a trough of the second Z-patternmember.
 7. The monolithic device of claim 6, wherein the first loop fitswithin a peak of the second Z-pattern member and the second loop fitswithin a trough of the first Z-pattern member.
 8. The monolithic deviceof claim 1, wherein each of the plurality of interconnecting memberscomprise a linear member and at least one interconnecting member of theplurality of interconnecting member couples a first Z-pattern member toa circumferentially offset peak of a second Z-pattern member positionedadjacent to the first Z-pattern member.
 9. The monolithic device ofclaim 8, wherein at least one interconnecting member of the plurality ofinterconnecting members couples the second Z-pattern member to acircumferentially offset peak of a third Z-pattern member in a directionopposite the circumferential offset of the coupling of the firstZ-pattern member and the second Z-pattern member.
 10. The monolithicdevice of claim 1, wherein the device is heat treated to optimize springback effects.
 11. The monolithic device of claim 1, wherein the deviceis selected from a group of devices consisting of: intravascular stents,stent-grafts, grafts, heart valves, venous valves, filters, occlusiondevices, catheters, sheaths, osteal implants, implantablecontraceptives, implantable antitumor pellets or rods, shunts andpatches, pacemakers, needles, temporary fixation rods, medical wires ormedical tubes for any type of medical device, or other implantablemedical devices.
 12. The monolithic device of claim 1, wherein thediversion of the majority of the fluid flow through the monolithicdevice provides an opportunity for an aneurysm of a blood vessel throughwhich the device is delivered to shrink over time.
 13. The monolithicdevice of claim 1, wherein the device includes an expanded state and acontracted state for delivery.
 14. The monolithic device of claim 2,wherein the end ring prevents cellular migration or is used for markerplacement.
 15. The monolithic device of claim 1, wherein the device isconfigured as an embolic protection stent cover or in an applicationwhere a low profile and high density pattern is desirable.
 16. Themonolithic device of claim 1, wherein the device is configured as aliner for a catheter tip, scaffold/indenter for drug-eluting balloons,and vascular stenting including: vulnerable plaque containment in eithercarotid or coronary arteries, flow diversion, adjunct to coiling inneurological applications, and vascular perforation.
 17. The monolithicdevice of claim 1, wherein the device is bent along its longitudinalaxis to conform to the shape or curvature of a blood vessel in which thedevice is delivered.
 18. The monolithic device of claim 1, wherein aradiopaque layer of tantalum is located between two layers of metal onthe monolithic device.
 19. The monolithic device of claim 1, furthercomprising a feature imparted onto the luminal or abluminal surface ofthe monolithic device.
 20. The monolithic device of claim 19, whereinthe feature is a plurality of microgrooves formed as a post-depositionstep or during deposition.